1. Field of the Invention
The present invention relates to an ostomy appliance comprising a body side member, a receiving bag and a disposable bag liner; and a disposable bag liner for use together with an ostomy appliance.
In connection with surgery for a number of diseases in the gastrointestinal or urinary tract a consequence is, in many cases, that the colon, the ileum or the ureter has been exposed surgically and the patient is left with an abdominal stoma, or, in nephrostomy or ureterostomy, the ureter or a catheter is exposed in the back or the chest region or abdominal region, and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma/ureter/catheter. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, an adhesive barrier member (or base plate) is attached to the wearer's abdomen/back/chest. In case of a one-piece appliance, a receiving member or bag is attached to the base plate. In case of a two-piece appliance, the adhesive barrier member forms part of a body side member and a receiving member or bag is attached releasably to the body side ostomy member for receiving exudates from the stoma.
When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy ember is left in place up to several days, and only the receiving member or bag attached to the body side member is replaced. The attachment means for attaching an ostomy receiving bag may be a system known per se comprising matching coupling rings or matching flanges and adhesive surfaces engaging with and sealing against a flange area of the body side member.
The service time of the body side ostomy member depends on the amount and aggressiveness of the exudates and of the tightness of the sealing between the ostomy and the body side ostomy member.
A known major problem with such receiving bags is that it can be difficult to dispose of the used bag in a convenient and hygienic manner. Some ostomists will cut the used bags open, e.g. by cutting off an edge thereof and depositing the contents into a WC for flushing away and disposing or depositing the empty bag in a waste bin. Such disposal of used bags and the contents therein is indeed unhygienic and unpleasant for the user, and in view of this a number of proposals have been made for ostomy bags which may be flushed down a WC.
2. Description of the Related Art
Thus, U.S. Pat. No. 5,423,782 (Wolrich) discloses a disposable ostomy bag liner apparatus including a unitary flexible bag having a main body portion, a tapered portion and a flange portion in which the tapered portion is disposed adjacent the main body portion and together, the main body portion and tapered portion define an interior portion of the bag for receiving and hold intestinal waste material. The patent discloses a bag liner for use by colostomy and some ileostomy patients which is easy to install in a conventional ostomy bag, which has provisions to allow for escape of gas admitted into the liner and which is relatively inexpensive to produce.
EP Patent No. 0 768 848 (Welland Medical Limited) discloses a biodegradable, flushable ostomy bag liner comprising inner walls formed from polyvinylacetate/polyvinylalcohol film of a grade which disintegrates within 60 seconds in water at 50° C. but retains its structural integrity in water at 25° C. for at least two days, outer walls formed from a non-woven fabric which disintegrates in water at 25° C., means defining an opening in the inner and outer walls for receiving bodily waste from the stoma patient, an adhesive flange being secured to at least an inner wall of the liner and surrounding the said opening, wherein the walls of the inner and outer bags are unconnected and form a non-laminar arrangement over the greater part of their area, but are connected around their peripheral margins and in the region of the adhesive flange.
EP Patent No. 0 703 762 (Welland Medical Limited) forms basis for the invention disclosed in EP Patent No. 0 768 848 above and discloses a drainage bag for receiving bodily waste, the drainage bag containing an outer bag, a water-impermeable inner bag enclosed within the outer bag, the inner bag being of a structure which is weakened upon immersion in a WC bowl such that it becomes limp and is less buoyant thereby enabling it to be flushed away easily, and means defining an orifice to enable bodily waste to be received by the inner bag in which the outer bag is water-impermeable and is formed from a material which acts as a barrier to flatus gases. The outer bag is provided with a flatus filter, the inner bag is permeable to flatus gases, and the outer and inner bags are detachably secured together in the region of the orifice.
GB Patent Application No. 2 306 889 (Alcare Co Ltd) discloses a body waste receiving appliance comprising an adhesive plate with an opening to a wastes discharge hole or opening formed on the surface of a human body, a first flange secured to the non-adhesive side of said adhesive plate and having an opening corresponding to the opening of said adhesive plate, a second flange detachably mounted at the opposite side, with reference to said adhesive plate, of said first flange and having an opening corresponding to the opening of said first flange and having an opening corresponding to the opening of said first flange, an outer pouch secured at the opposite side, with reference to the adhesive plate, of said second flange and having an opening corresponding to the respective openings of said adhesive plate, said first flange and said second flange, and an inner pouch for receiving the body wastes through the respective openings of said adhesive plate and said first flange, said inner pouch being housed inside the outer pouch in such a manner as to be separable therefrom, said outer pouch being formed of a non-water-soluble film, while said inner pouch being formed of a water-soluble film which is dissolved or disintegrated in water, said inner pouch being replaceable.
GB Patent Application No. 2 265 832 (Bettison) discloses an ostomy bag with an inner dividing means in the form of an open, inner bag communicating with the internal space of the outer bag having the overall effect of dividing the interior of the bag into an inlet section and an outlet section communicating in the vicinity of the bottom of the bag.
EP Patent Application No. 0 821 925 (Quacquarella) discloses an ostomy appliance comprising a reusable outer bag and a disposable inner bag, means for securing the two bags together and to the stoma, means for inserting and removing the inner bag from the outer bag, and means for closing the outer bag once the inner bag is in place.
The purpose of the present invention is to provide an ostomy appliance combining the advantages of using separate, flushable inner bags with a safe, hygienic and discreet management of the collected waste with maximum safety against soiling parts of the appliance not to be substituted when changing the inner bag. Non of the above-referenced patents disclose an ostomy bag comprising a disposable inner bag which stays with full engagement with the coupling area of a body side member after detaching the outer bag.